CMS Releases Proposed Rule for Stage 2 Meaningful Use of Electronic Health Records

On Thursday, February 23, 2012, the Centers for Medicare and Medicaid Services (CMS), pursuant to the Health Information Technology for Economic and Clinical Health (HITECH) Act, released a 455-page Proposed Rule specifying the Stage 2 criteria that eligible professionals (EPs), eligible hospitals and critical access hospitals (CAHs) must meet in order to qualify for Medicare and/or Medicaid incentives related to electronic health records (EHRs).  The Proposed Rule also proposes to modify certain Stage 1 criteria, as well as criteria that apply regardless of Stage, as previously published in the Final Rule on July 28, 2010 in the Federal Register.  The proposed provisions related to Medicaid (calculations of patient volume and hospital eligibility) would take effect shortly after the finalization of the Proposed Rule and would not be subject to the proposed one-year delay for Stage 2 meaningful use of a certified EHR.  The Proposed Rule states that the changes to Stage 1 would take effect for 2013, but that most changes would be optional until 2014.  Last but not least, the Proposed Rule addresses the Medicare payment adjustments that will take place for EPs, eligible hospitals and CAHs who fail to demonstrate a meaningful use of certified EHRs by 2015 and proposed exceptions to such adjustments.

ONC Announces Text4Health Task Force

In an article titled, “Use of electronic communications with patients,” posted to this blog on December 18, 2009, I discussed the stated goal under the Health Information Technology for Economic and Clinical Health (HITECH) Act  to “[p]rovide patients and families with timely access to data, knowledge, and tools to make informed decisions and to manage their health.” The article explored whether and to what extent patient messaging, including text messaging, might be used to achieve this HITECH Act goal.  The U.S. Department of Health and Human Services (HHS) also is exploring ways to integrate text messaging into individual health management.  On September 19, 2011, HHS announced the formation of the Text4Health Task Force, with specific recommendations that support health text messaging and mobile health (mHealth) programs.  The HHS press release states: “The department has been actively exploring means to capitalize on the rapid proliferation of mobile phone technology and platforms, such as text messaging, to develop programs and/or partnerships with the overall aim of improving public health outcomes.”  The HHS press release cites certain smoking cessation programs that utilize text messaging as representative of the direction in which this technology can be further exploited to improve population health.  Among its recommendations, the Text4Health Task Force includes a recommendation related to electronic health records (EHRs) and, more specifically, recommends that “HHS align health text messaging/mHealth activities with other HHS Health IT priorities.”  To read the HHS Text4Health Task Force recommendations, click here.

Proposed Federal Regulation Requires HIPAA-Covered Labs to Release Test Results to Patients

On September 12, 2011, the Office of National Coordinator (ONC) for the United States Department of Health & Human Services (HHS) announced a Proposed Rule that will enable direct access to laboratory test results by patients.  Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), laboratories must hold a CLIA certificate in order to perform one of three levels of complex laboratory tests regulated by CLIA.  Even before the passage of the Health Information Technology for Economic and Clinical Health Act (HITECH Act), concerns have been expressed regarding the lack of clarity under state law, and the literal prohibition in some states, regarding whether a CLIA laboratory that is independent (as opposed to hospital based) may release laboratory test results directly to a patient.